4.3. Surgical methods

In T 2699/17 the application related to the guided expansion of an elastomeric material within the sulcus of a tooth. In this way, the gingiva was retracted from the tooth, such that an appropriate impression of the tooth could be obtained, which was then used in the manufacture of the crown restoration. The board referred to T 1695/07 (point 6.3 of the Reasons) for a review of the understanding of what constituted a "treatment by surgery" within the meaning of Art. 53(c) EPC after G 1/07 (OJ EPO 2011, 134). The criteria as defined in G 1/07 and as summarised in T 1695/07 were then applied to the specific method claimed. In the case at hand, the board held that minor injury of the epithelium could occur. However, the detailed evidence provided by the appellant demonstrated that periodontal attachment fibres were not violated, that an index of gingival irritation and inflammation increased after the retraction but returned to baseline levels within seven days, and that the periodontium was respected and the junctional epithelium remained intact. It then had to be examined whether the method qualified as "substantial physical intervention on the body", i.e. whether the health risk was a substantial health risk within the meaning of G 1/07. For that evaluation, different approaches have been suggested in the case law, namely, the "risk matrix" in decision T 663/02 and a "more abstract risk criterion" in decision T 1695/07 (see point 12.2.4 of the Reasons). As in T 1695/07 the "risk matrix" approach of T 663/02 was rejected with a view to its practical feasibility and the board followed the "more abstract risk criterion" approach, limiting the assessment to a more abstract basis, i.e. to the question "Is a certain health risk present?" and "Is it substantial?". For the specific method claimed, the board came to the conclusion that though certain health risks were present, these were at a level equal to those present in the methods which G 1/07 considered not to involve a substantial health risk. Thus, the claimed method did not comprise or encompass an invasive step representing a substantial physical intervention on the body and did not entail a substantial health risk in the sense of G 1/07.

In T 1731/12 the invention concerned a device for the desynchronisation of the activity of pathologically active brain areas comprising means for stimulating brain regions. Assessing whether the device was excluded from patentability under Art. 53(c) EPC, the board considered T 775/97. It had dealt with a claim for a new product made by a surgical step in the human body from two parts known individually. It had been decided there that a European patent could not be granted for a product defined by a construction that could be arrived at only by a surgical method step in a human or animal body. It was generally accepted, and explained for instance in the Enlarged Board decisions dealing with medical methods (most recently in G 1/07, OJ EPO 2011, 134), that a single surgical step was sufficient for a multi-step method to be considered unpatentable. In T 775/97 that approach had been applied to particular products. The board saw no reason to diverge from T 775/97. It agreed with the thinking that a product defined by a surgical step could not exist without it, and thus that the surgical step was part of the claimed product. Moreover, the exclusion of such a product from patentability was not contrary to the second clause of Art. 53(c) EPC, which provided that products for use in therapeutic or surgical methods were patentable. Otherwise medical and veterinary practitioners' freedom would be limited, as also discussed for example in G 1/07. The board saw a fundamental difference between the actions of "using" and "making" a product. Using patented subject-matter was generally allowed once that subject-matter had been duly purchased. To be allowed to make a patented product, by contrast, medical staff would need to purchase a licence for the process of making it; where that process involved a surgical or therapeutic method step, that would interfere precisely with the freedom of medical staff that the exclusion from patentability under Art. 53(c) EPC intended to protect. There had never been any divergence from the case law established in T 775/97. Decisions citing T 775/97 in this regard (T 1695/07, T 1798/08) had concluded that the devices claimed in those cases were not excluded from patentability under Art. 53(c) EPC precisely because they were not arrived at by surgical steps. A device defined by a feature that could be arrived at only by a surgical or therapeutic step was excluded from patentability under Art. 53(c) EPC (in line with T 775/97).